Pti Annuloplasty Ring(Sterile)
FDA 510(k) K905175 · Pioneering Technologies, Inc.
510(k) numberK905175
Submission
- Device name
- Pti Annuloplasty Ring(Sterile)
- Applicant
- Pioneering Technologies, Inc.
Wheat Ridge, CO, US - Received
- November 19, 1990
- Decision date
- February 14, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KRH – Ring, Annuloplasty
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3800
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code KRH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261707 | MEMO 4D Curve Semirigid mitral annuloplasty ringKRH · Special | Corcym S.r.l. | 06/18/2026SE |
| K260498 | TriMemo SEMIRIGID ANNULOPLASTY RINGKRH · Abbreviated | Corcym S.r.l. | 04/14/2026SE |
| K253232 | Seguin Annuloplasty RingKRH · Special | Abbott Medical | 10/29/2025SE |
| K251982 | Edwards MC3 Tricuspid annuloplasty ring (4900)KRH · Abbreviated | Edwards Lifesciences, LLC | 09/23/2025SE |
| K251688 | Carpentier-Edwards Physio Annuloplasty Ring (4450)KRH · Abbreviated | Edwards Lifesciences, LLC | 09/17/2025SE |
| K250859 | TransForm McCarthy Mitral Annuloplasty Ring (TF)KRH · Traditional | Genesee Biomedical, Inc. | 07/25/2025SE |
| K232599 | TransForm McCarthy Mitral Annuloplasty Ring (TF)KRH · Traditional | Genesee Biomedical, Inc. | 04/09/2024SE |
| K230679 | WellsForm Tricuspid Annuloplasty Band (WF)KRH · Traditional | Genesee Biomedical, Inc. | 05/26/2023SE |
| K230318 | Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo…KRH · Traditional | Corcym S.r.l. | 04/07/2023SE |
| K202253 | TruForm Sievers Annuloplasty RingKRH · Traditional | Genesee Biomedical, Inc. | 10/06/2020SE |
More from Genesee Biomedical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K922025 | Anastomart(Tm) Coronary Bypass Graft Markers/ModifDSY · Traditional | 09/22/1992SE |
| K905068 | Pti Intra-Art (TM) Pick-Up WicksEFQ · Traditional | 12/31/1991SE |
| K910067 | Pti Sternal Closure Wire SutureGAQ · Traditional | 05/06/1991SE |
| K905067 | Pti Anastomark Flexible Coronary Bypass GraftDSY · Traditional | 03/18/1991SE |
| K901815 | Modified Sterilization of Intra-Art(Tm) CoronaryDRE · Traditional | 07/03/1990SE |
| K901682 | Pti Anastomark(Tm) Coronary Bypass Graft MarkersDSY · Traditional | 07/03/1990SE |
| K901531 | Pti Intra-Artr Reusable Coronary Artery ProbeDNP · Traditional | 06/20/1990SE |
| K901575 | Reusable TENS Paravertebral Pad #641 Back ElectrodGXY · Traditional | 05/02/1990SE |
| K897075 | Pti Intra-Art(Tm) Ansari Saphenous Vein HolderDXC · Traditional | 04/10/1990SE |
| K894684 | Pti Intra-Art Internal Mammary Artery Cannula KitDWF · Traditional | 10/17/1989SE |
Questions and answers
When was Pti Annuloplasty Ring(Sterile) cleared by the FDA?
Pti Annuloplasty Ring(Sterile) (K905175) received a 510(k) decision of Substantially Equivalent on February 14, 1992, 452 days after the submission was received.
What is the product code of K905175?
The FDA product code is KRH – Ring, Annuloplasty, a Class II (moderate risk) device regulated under 21 CFR 870.3800.